# K980362: Mri Compatible Monitor and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Engstrom, Inc.
- Decided: Jun 30, 1998 after 152 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Datex-Engstrom MRI Patient Monitor and accessories is indicated for monitoring of ECG waveform for Heart Rate and Asystole detection, SpO₂, Non-invasive blood pressure (NIBP), airway gases, anesthetic agents, airway flow, airway pressure and airway volume on patients during MR imaging. It is indicated for use inside the MRI room mounted outside the 20 Gauss line and with magnets of field strength 1.5 Tesla or less. SpO₂ monitoring is indicated only with the use of Datex-Engstrom sensors specifically designed for use in the MRI environment. ECG monitoring is indicated only with use of the MRI ECG lead set.

Source page: https://510kreport.com/device/K980362
Methodology: https://510kreport.com/methodology